This protocol applies to patients with chronic urticaria who are already receiving a second-generation H1-antihistamine with an add-on biologic or targeted agent — omalizumab, dupilumab, or remibrutinib — and have still not reached complete symptom control.
Adding omalizumab, dupilumab, or remibrutinib to a second-generation H1-antihistamine did not achieve the clinical target of complete symptom control — defined as a continuous urticaria activity score (UAS) of 0 and a urticaria control test (UCT) score of 16. This unmet target is what triggers escalation to the next step.
The objective remains unchanged: complete symptom control, measured as a continuous UAS of 0 and a UCT of 16 — treating the disease until it is gone, as efficiently and safely as possible.
When the prior biologic or targeted therapy has not met the clinical targets, the next step involves adding a different class of agent — ciclosporin — on to the continued second-generation H1-antihistamine.
DOI: 10.1111/all.70210
We suggest using ciclosporin for the treatment of patients with CU unresponsive to licensed treatments or if these are not available.
Patients with CSU who do not show sufficient benefit from treatment with H1-antihistamines, especially if they are also unresponsive to omalizumab, can alternatively be treated with ciclosporin 3–5 mg/kg per day.
The goal of treatment is to treat the disease until it is gone, as efficiently and as safely as possible, aiming at a continuous complete control (consistently UAS = 0/UCT = 16) and a normalization of quality of life.
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